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临床试验/NCT02041156
NCT02041156Unknown不适用

Long-term Effects of Basic Aerobic Training Combined With Either Resistance - or Balance Training in CKD Patients - a Comparative Study

Region Skane2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
Region Skane
入组人数
150
试验地点
2
主要终点
Physical function

研究概览

简要总结

The investigators' purpose is to study which exercise training modality: aerobic physical activity in conjunction with either resistance training or balance training, is most beneficial in patients with chronic kidney disease (CKD 4-5: GFR < 30 ml/min/1.73mUP[2]). Furthermore, our purpose is to evaluate the long-term effects of exercise training on functional status, cardiovascular morbidity, blood pressure control, heart rate variability, cardiac function, inflammation, body composition, nutritional status, progression of uraemia and health related quality of life. This interventional study is prospective, randomized and controlled comprising 150 prevalent and incident patients from our outpatient clinic. Patients are invited to participate in the study consecutively, irrespective of basic functional status. At start patients are randomised either to resistance or balance training and the programme is adapted and individualised to each patient's actual physical status and ability. The exercise prescription is to exercise for 30 minutes/day, 5 days/week, keeping the intensity constant at a level of "somewhat strenuous" to "strenuous" on the Borg scale rate of perceived exertion. The total observation period is 12 months with checks every four months. Although exercise training is a recommended therapy in CKD, there is a lack of medical and scientific evidence on optimal prescription. We hope that this study will provide evidence-based knowledge on exercise prescription and its effects on various risk factors in CKD patients. Finally, if patients achieve a higher degree of physical functional capacity they should be able to maintain an autonomous lifestyle, resulting in considerable reductions in societal costs for care and transportation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CKD 4 and 5
  • over 18 years of age
  • no neurological or orthopedic impairments
  • stable cardiac status

排除标准

  • not on renal replacement therapy
  • no severe electrolyte disturbances

结局指标

主要结局

Physical function

时间窗: 4, 8 and 12 months

6 minutes walking test, 30 seconds sit to stand, stair climbing, handgrip strength, Isometric quadriceps strength, functional reach, standing heel rise, toes lift, picking-up test, Berg balance scale

次要结局

  • Bone density(12 months)
  • Cardiovascular morbidity(after 12 months)
  • Inflammatory activity(4, 8 and 12 months)
  • Quality of Life(4,8 and 12 months)
  • Body composition(after 12 months)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (2)

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